FREE ON-DEMAND WEBINAR

PMCF as Part of Lifecycle Management – Insights from Working with Notified Bodies

The role of Post-Market Clinical Follow-up (PMCF) in medical device lifecycle management has undergone a fundamental shift. Once seen as an isolated regulatory task, PMCF is now recognized as a cornerstone of integrated lifecycle activities. This evolution, shaped by insights from interactions with multiple Notified Bodies under the EU MDR, underscores the need for manufacturers to adopt a proactive and strategic approach.

This webinar explores how PMCF can be leveraged not only to maintain compliance but also to drive continuous improvement, innovation, and competitive differentiation. By integrating PMCF into lifecycle management processes, medical device companies can stay ahead in an increasingly complex regulatory environment.

What You’ll Learn:

  • A New Approach to PMCF: Explore the paradigm shift from one-off regulatory activities to integrated lifecycle strategies.
  • PMCF and Risk Management Continuum: Understand how PMCF strengthens the link between risk assessment, risk mitigation, and device safety.
  • Driving Innovation with PMCF Data: Learn how insights gained from PMCF activities can lead to design enhancements and fuel new product development.
  • Turning Compliance into Competitive Advantage: Discover how an effective PMCF strategy can differentiate your product in the market and improve stakeholder confidence.

Why This Matters:
Today’s medical device manufacturers are navigating more stringent requirements and greater expectations from regulators. PMCF, when strategically managed, becomes more than a compliance necessity—it becomes a vital tool for lifecycle risk management, innovation, and market leadership.

Watch the Webinar!

PMCF Evnia Webinar
Who should attend?
  • Clinical Affairs Professionals and Management
  • Clinical Operations Professionals and Management
  • Regulatory Professionals and Management
  • Medical Device Executives
  • Quality Managers
  • Product Development and Lifecycle Management Leaders
Watch Now!  

Hosted by

Chris Rush headshot1
MODERATOR:
CHRIS RUSH

Solutions Engineer,
Greenlight Guru

EVNIA_Primary_Logo_Blue
About Evnia

Founded in 2015 in Copenhagen, Evnia has become 𝘁𝗵𝗲 𝗺𝗶𝘀𝘀𝗶𝗻𝗴 𝗹𝗶𝗻𝗸 𝗯𝗲𝘁𝘄𝗲𝗲𝗻 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗿𝘀, 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘀, 𝗮𝗻𝗱 𝗶𝗻𝘃𝗲𝘀𝘁𝗼𝗿𝘀 working for healthcare innovation and the improvement of patients’ quality of care and life. 

𝗘𝘃𝗻𝗶𝗮 𝗶𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝗲𝘀 𝗮 𝗽𝗮𝗿𝗮𝗱𝗶𝗴𝗺 𝘀𝗵𝗶𝗳𝘁 𝗶𝗻 𝘁𝗵𝗲 𝗺𝗲𝗱𝘁𝗲𝗰𝗵 𝗰𝗼𝗻𝘀𝘂𝗹𝘁𝗶𝗻𝗴 𝘀𝗲𝗿𝘃𝗶𝗰𝗲𝘀 𝗯𝘆 𝗼𝗳𝗳𝗲𝗿𝗶𝗻𝗴 𝗲𝘅𝗽𝗲𝗿𝘁 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝗹𝗶𝗳𝗲 𝗰𝘆𝗰𝗹𝗲 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝘀𝗲𝗿𝘃𝗶𝗰𝗲𝘀. We serve MedTech and BioTech companies of all sizes, including Billion+, Midsize, and Startups, while remaining flexible to the needs and integration our partners require.
We support manufacturers throughout the medical device development lifecycle. From the early concept and design stages to verification and validation, until market access and post-market adulthood, 𝗘𝘃𝗻𝗶𝗮 𝗲𝗻𝗮𝗯𝗹𝗲𝘀 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗮𝗻𝗱 𝗲𝗻𝘀𝘂𝗿𝗲𝘀 𝗮𝘂𝗱𝗶𝘁 𝗮𝗻𝗱 𝗶𝗻𝘀𝗽𝗲𝗰𝘁𝗶𝗼𝗻 𝗿𝗲𝗮𝗱𝗶𝗻𝗲𝘀𝘀.

Our know-how and cluster of interconnected services brings to the table 𝗮 𝗰𝗼𝗺𝗽𝗿𝗲𝗵𝗲𝗻𝘀𝗶𝘃𝗲, 𝘁𝗶𝗺𝗲- 𝗮𝗻𝗱 𝗰𝗼𝘀𝘁-𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝘀𝗲𝗿𝘃𝗶𝗰𝗲. A 𝗼𝗻𝗲-𝘀𝘁𝗼𝗽-𝘀𝗵𝗼𝗽 𝘀𝗼𝗹𝘂𝘁𝗶𝗼𝗻 𝘁𝗼 𝗮𝗱𝗱𝗿𝗲𝘀𝘀 𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰 𝗮𝗻𝗱 𝗼𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗻𝗲𝗲𝗱𝘀 𝘁𝗵𝗿𝗼𝘂𝗴𝗵𝗼𝘂𝘁 𝘁𝗵𝗲 𝗹𝗶𝗳𝗲𝘁𝗶𝗺𝗲 𝗼𝗳 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲s or in-vitro diagnostics.

  • Due Diligence
  • Regulatory Strategy
  • Clinical Development Strategy
  • Quality Management System
  • Technical Documentation
  • Clinical Evaluation
  • Post-Market Surveillance and PMCF
  • Clinical Data & Real-World Evidence
  • Market Access and Reimbursement
  • EU and UK Representation Services

Visit our homepage to learn more. 

Greenlight Guru logo

About Greenlight Guru

Greenlight Guru is the leading connected, cloud-based platform purpose-built for MedTech companies. The end-to-end solution streamlines product development, quality management, and clinical data management by integrating cross-functional teams, processes, and data throughout the entire product lifecycle.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster and with less risk.

Visit our homepage to learn more.

Featured In